인공심장 치환 기기 시장 : 규모, 점유율, 동향 분석(2026-2032년)

Global Artificial Heart Replacement Device Market Report to 2032

The global artificial heart replacement device market was valued at $11.8 million in 2025. It is expected to grow at a compound annual growth rate (CAGR) of 0.21%, reaching $12 million by 2032.

This report covers the global market for artificial heart replacement devices, including mechanical devices that replace the lower chambers of the heart and restore blood circulation.

The analysis includes unit sales, average selling prices (ASPs), procedure numbers, market size, market shares, growth trends, market forecasts through 2032, and historical data back to 2022.

Market growth is supported by FDA approval of the 50cc Total Artificial Heart(TM), potential destination therapy approval, and favorable reimbursement. However, competition from ventricular assist devices and the lack of permanent artificial heart replacement options continue to limit stronger market expansion.

Market Overview

The global artificial heart replacement device market includes mechanical devices that replace the lower chambers of the heart. Once implanted, the artificial heart takes over the pumping function and supports blood circulation throughout the body.

Artificial hearts are currently used primarily as temporary bridge-to-transplant solutions. They are designed to keep patients stable and healthy enough to receive a donor heart when no other suitable option is available.

This is a relatively early-stage segment within the cardiac surgery device market. The market is characterized by ongoing research, development, and clinical evaluation, with manufacturers working to improve durability, biocompatibility, and patient quality of life.

Multiple devices are expected to continue moving through clinical trials and regulatory pathways across key global regions. However, adoption remains limited due to the small eligible patient population, competition from VADs, and the lack of broadly available permanent artificial heart replacement devices.

Market Drivers

FDA Approval of 50cc Artificial Heart

The FDA approval of the 50cc Total Artificial Heart(TM) as a bridge-to-transplant device in March 2020 expanded the eligible patient population for artificial heart replacement.

The 50cc device is suitable for patients with smaller body frames who may not fit the traditional 70cc Total Artificial Heart(TM). This is especially important for women and adolescents, who may have previously had fewer artificial heart options.

By broadening access to smaller patients, the 50cc device supports market growth in a segment with a narrow patient base. Even modest expansion in eligibility can be meaningful because artificial heart replacement remains a low-volume, highly specialized market.

FDA Approval of Artificial Heart for Destination Therapy

Destination therapy represents a potential growth opportunity for the artificial heart replacement device market. SynCardia's investigational device exemption application to study the Total Artificial Heart(TM) for destination therapy was approved in December 2014.

Approval for destination therapy would allow artificial hearts to be used in a new cohort of patients who are not expected to receive a heart transplant. This would expand the potential patient population beyond bridge-to-transplant cases.

If artificial hearts become approved and adopted for destination therapy, they could serve patients with irreversible biventricular failure who need long-term support. This would create a broader clinical role and support future market expansion.

Favorable Reimbursement

Favorable reimbursement remains an important market driver. The Centers for Medicare and Medicaid Services has stated that the Total Artificial Heart fulfills a role that no other mechanical circulatory support device can for patients with irreversible biventricular failure.

Hospitals implanting artificial hearts are reimbursed at the same rate as a heart transplant, plus up to $53,000 more through new technology add-ons. This means hospitals can earn up to $345,000 for an artificial heart procedure after patient discharge.

This reimbursement structure more than covers the cost of the device and makes procedures more economically feasible for hospitals. As long as reimbursement policies remain favorable, they will continue to support market adoption.

Market Limiters

VAD Market

Ventricular assist devices compete with artificial hearts for a similar patient population. Bridge-to-transplant VADs serve a similar temporary support role, while destination therapy VADs serve a similar long-term support role.

One major difference is that artificial heart replacement requires part or all of the natural heart to be removed. This eliminates the chance of native heart recovery. VADs, by contrast, assist the natural heart rather than replacing it.

Although artificial hearts may offer important benefits in certain patients with irreversible biventricular failure, VADs remain a major competing technology. As long as VADs and artificial hearts compete for overlapping patient groups, VADs will continue to limit artificial heart market growth.

Lack of Permanent Artificial Heart Replacements

The lack of permanent artificial heart replacement options remains a major limiter. In 2009, the first AbioCor(R) implant was performed, but the patient passed away approximately one month afterward.

Since that procedure, Abiomed has not performed additional implants and has shifted its focus to other segments. This absence has contributed to the lack of permanent artificial heart replacement devices in the market.

Without broadly available permanent artificial heart options, the market remains focused mainly on bridge-to-transplant therapy. This limits unit sales and prevents the market from reaching a larger destination therapy population.

Limited Commercial Scale

The artificial heart replacement device market remains very small compared with other cardiac surgery device segments. It serves a narrow patient group and requires specialized clinical expertise, hospital infrastructure, and transplant-center coordination.

Even when clinical need exists, artificial heart replacement is not a routine procedure. Patient selection is highly specific, and many potential patients may be treated with VADs or other mechanical circulatory support devices.

This limited commercial scale constrains market growth. Manufacturers must continue investing in research, regulatory work, and clinical evidence while adoption remains concentrated in select centers and specialized use cases.

Market Coverage and Data Scope

• Quantitative coverage: Market size, market shares, procedure numbers, market forecasts, market growth rates, units sold, and average selling prices.
• Qualitative coverage: Market drivers and limiters, competitive analysis, recent mergers and acquisitions, company profiles, product portfolios, and leading competitors.
• Time frame: Base year 2025, forecasts to 2032, and historical data back to 2022.
• Market modeling: Revenue is analyzed using unit sales and ASPs, supported by procedure numbers, competitive share analysis, and forecast assumptions.
• Device scope: The report covers artificial heart replacement devices that replace the lower chambers of the heart and take over blood pumping function, primarily as a temporary solution for patients awaiting heart transplantation.

Markets Covered and Segmentation

Artificial Heart Replacement Device Market

The report covers the global artificial heart replacement device market as a dedicated segment within cardiac surgery and mechanical circulatory support.

Artificial heart replacement devices are mechanical devices designed to replace the pumping function of the lower chambers of the heart. These devices are used in patients with severe biventricular failure, most often as a bridge to heart transplantation.

The market is analyzed by market size, market shares, procedure numbers, market forecasts, market growth rates, units sold, and average selling prices.

The report evaluates demand based on patient eligibility, bridge-to-transplant use, destination therapy potential, reimbursement conditions, clinical trial activity, regulatory pathways, and competition from VAD technologies.

This structure helps manufacturers, investors, and strategy teams understand how artificial heart replacement fits within advanced heart failure treatment and how the market may evolve as new devices and indications develop.

Competitive Analysis

SynCardia remains the leading company in the global artificial heart replacement market. Its Total Artificial Heart(TM) was the first total artificial heart to receive U.S. FDA approval and is commercially available in both the United States and Canada.

Beyond these markets, the device has been implanted in select cases and clinical studies across more than 27 countries worldwide. SynCardia is expected to retain a significant share of the global market over the forecast period.

However, SynCardia's long-standing monopoly is expected to gradually diminish as additional total artificial heart devices from competing manufacturers receive regulatory approval in other regions.

CARMAT was the second-leading competitor in the artificial heart device market in 2025, supported by its Aeson(R) total artificial heart. The Aeson system is intended for patients with end-stage biventricular heart failure and is used mainly as a bridge-to-transplant solution rather than permanent replacement therapy.

The Aeson device received CE Mark approval in Europe and has been implanted in a limited number of patients at selected centers, giving CARMAT a narrow but established commercial presence. Despite its technology differentiation, CARMAT faced financial and operational challenges and entered court-supervised restructuring in 2025, with assets and activities transferred to a new entity to allow continued development and limited commercialization.

Technology and Practice Trends

Bridge-to-Transplant Use

Bridge-to-transplant use remains the main clinical role for artificial heart replacement devices. These devices help keep patients stable while they wait for a donor heart.

This role is especially important for patients with severe biventricular failure who may not be adequately supported by other mechanical circulatory support options.

Smaller-Frame Patient Access

The 50cc Total Artificial Heart(TM) expanded access for smaller-frame patients, including women and adolescents. This is important because size limitations previously restricted eligibility for some patients.

Smaller device options may help broaden the treatable population in a market with limited procedure volumes.

Destination Therapy Potential

Destination therapy remains a major future opportunity. If artificial hearts are approved for use in patients who are not expected to receive a transplant, the market could expand beyond temporary bridge-to-transplant use.

However, this opportunity depends on clinical evidence, regulatory approval, long-term safety, and device durability.

Durability and Biocompatibility Improvements

Manufacturers are investing in next-generation designs aimed at improving durability and biocompatibility. These improvements are needed to support longer use, reduce complications, and improve patient quality of life.

Progress in these areas will influence how far the market can expand beyond highly selected patients.

Limited Commercial Availability

Commercial availability remains limited. SynCardia is established in North America, while CARMAT has a limited presence in Europe through selected centers.

Broader adoption will depend on regulatory progress, manufacturing stability, clinical confidence, and hospital readiness.

Competition from VADs

VADs remain the main competing technology. They can support bridge-to-transplant and destination therapy patients while preserving the natural heart.

Artificial hearts must demonstrate clear value in patients where VADs are insufficient, especially those with irreversible biventricular failure.

Geography

This report provides global coverage across North America, Europe, Asia-Pacific, Latin America, the Middle East, and Africa.

Why This Report

• How large is the global artificial heart replacement device market today, and how much is it expected to grow through 2032?
• How are unit sales, procedure numbers, ASPs, and market values changing over time?
• What role do artificial hearts play in bridge-to-transplant therapy?
• How does the 50cc Total Artificial Heart(TM) expand eligibility for smaller-frame patients?
• What is the potential market impact of destination therapy approval?
• How do reimbursement policies affect hospital adoption of artificial heart procedures?
• Why do VADs remain a major competing technology?
• What limits the development of permanent artificial heart replacement devices?
• Which companies lead the global artificial heart replacement device market?
• How are SynCardia and CARMAT positioned in the competitive landscape?

The Global Artificial Heart Replacement Device Market Report from iData Research answers these questions with device-level analysis, procedure-based modeling, ASP data, company share insights, and forecasts through 2032. Use it to evaluate demand, benchmark competitors, understand artificial heart development trends, and support commercial planning in the global artificial heart replacement device market.

TABLE OF CONTENT

Research Methodology

• Step 1: Project Initiation & Team Selection
• Step 2: Prepare Data Systems And Perform Secondary Research
• Step 3: Preparation For Interviews & Questionnaire Design
• Step 4: Performing Primary Research
• Step 5: Research Analysis: Establishing Baseline Estimates
• Step 6: Market Forecast And Analysis
• Step 7: Identify Strategic Opportunities
• Step 8: Final Review And Market Release
• Step 9: Customer Feedback And Market Monitoring

Impact Of Global Tariffs

Artificial Heart Replacement Device Market

• 20.1 Executive Summary
  • 20.1.1 Global Artificial Heart Replacement Device Market Overview
  • 20.1.2 Competitive Analysis
  • 20.1.3 Procedures Included
  • 20.1.4 Regions Included
• 20.2 Introduction
• 20.3 Procedure Numbers
• 20.4 Market Analysis And Forecast
• 20.5 Drivers And Limiters
  • 20.5.1 Market Drivers
  • 20.5.2 Market Limiters
• 20.6 Competitive Market Share Analysis

Appendix